General Information

Age Group

Status

Recruiting

Protocol Number

NCT05027685

Background Information

The objective of the Global GPS Registry, including the US arm of the Global Paradise System Post Approval Study (US GPS), is to evaluate the real-world use of the Paradise System as per approved labeling. In addition, US GPS will collect data in patient populations underrepresented within the RADIANCE clinical program.

Offered At

Inova Fairfax Medical Center 
3300 Gallows Rd  
Falls Church, VA, 22042
Principal Investigator

Behnam N. Tehrani, MD

Eligibility Information

  • Signed and dated study informed consent 
  • Documented history of hypertension 
  • Documented history of prior or current antihypertensive medication(s) 
  • Mean seated office systolic BP at screening ≥ 140 mmHg 
  • Mean pre-procedure home systolic BP of ≥ 135 mmHg 
  • Estimated glomerular filtration rate (eGFR) of ≥30 mL/min/m2 

Ineligibility Information

  • Patient lacks appropriate renal anatomy for any treatment with the Paradise Catheter 
  • Patient under the age of 18 years old at the time of consent 
  • Patient is pregnant 
  • Patients with transplanted kidney 
  • Presence of abnormal kidney (or secreting adrenal) tumor